An Early Phase 1 interventional study of Desert Harvest Aloe Vera Capsules and Placebo Capsules in Interstitial Cystitis, Chronic Interstitial Cystitis and Bladder Pain Syndrome, sponsored by Wake Forest University Health Sciences. Recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-07-28.
Sponsored by Wake Forest University Health Sciences · Early Phase 1, Interventional, and Treatment
The purpose of this study is to assess the safety and efficacy of super-concentrated, freeze-dried aloe vera capsules for treatment of interstitial cystitis.
After being informed about the study and potential risks, all participants who have provided written informed consent will be screened to determine eligibility for study entry. Participants who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 4:1 ratio to aloe vera (study group) or placebo (control group), respectively. The dosing regimen will be increased by 3 capsules every month for 3 months and then reduced by 2 capsules every week during the fourth month for both groups. Participants will remain in the study for sixteen weeks.
236 studies on the registry are indexed under Cystitis, Interstitial; 35 are open to participants now.
This study's planned enrollment of 30 is below the median of 51 across 158 interventional studies indexed under Cystitis, Interstitial.
Browse Cystitis, Interstitial studies →Wake Forest University Health Sciences is the lead sponsor of 1,351 studies on the registry; 201 are open to participants now.
Of its 332 completed or terminated interventional studies of FDA-regulated products, 251 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Male-Specific Exclusion Criteria:
Female-Specific Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will self-administer Desert Harvest super-concentrated, freeze-dried aloe vera capsules orally over a sixteen week period. The dosing regimen includes administering 3 capsules twice daily for the first month, 3 capsules three times daily for the second month, and 4 capsules three times daily for the third month. During the fourth month, participants will administer 10 capsules per day the first week (4 in the morning, 2 in the afternoon, and 4 in the evening), 8 capsules per day the second week (4 in the morning, 4 in the evening), 6 capsules per day the third week (3 in the morning, 3 in the evening), and 4 capsules per day the fourth week (2 in the morning, 2 in the evening). A participant must stay on a minimum of 6 capsules per day for the first three months in order to remain in the study.
Drug: Desert Harvest Aloe Vera Capsules
Participants will self-administer placebo capsules orally, matching the dosing regimen of the experimental treatment, over a sixteen week period. Placebo capsules will be identical in appearance and packaging to the experimental capsules.
Other: Placebo Capsules
600 mg pure, freeze-dried aloe vera super-concentrate with a minimum of 200 mg glycosaminoglycan per capsule.
Also known as: Desert Harvest Super-Concentrated, Freeze-Dried Aloe Vera
550mg of Avicel microcrystalline cellulose per two-piece, hard-shelled gelatin capsule.
Also known as: Avicel
Safety, as measured by the Change in the number and severity of adverse events (AE)
Non-serious adverse events will be defined as any new medical condition or worsening of an existing medical condition, not to include the disease being studied. Severe adverse events will be defined as any adverse event that results in death, a life-threatening event, inpatient hospitalization, prolongation of existing hospitalization (hospitalization for an elective treatment of a pre-existing condition will not be considered a serious event), disability or incapacity, or an important medical event, which, though not included previously, may jeopardize the participant and may require medical or surgical intervention.
Time frame: Week 16
Change in Interstitial cystitis (IC)/bladder pain syndrome (BPS) symptoms, as measured by the O'Leary Sant Questionnaire
The O'Leary-Sant questionnaire is composed of the Interstitial Cystitis Symptom Index (ICSI) and Problem Index (ICPI) which contains four questions related to urinary and pain symptoms. For the ICSI (score range: 0-19 points), 3 of the 4 questions utilize a range of 0-5 with 0 indicating the symptom is never experienced and 5 indicating the symptom is almost always experienced. The fourth question utilizes a range of 0-4 with 0 indicating the symptom is never experienced and 4 indicating the symptom is almost always experienced. For the ICPI (score range: 0-16 points), all four questions utilize a range of 0-4 with 0 indicating it is no problem and 4 indicating it is a big problem.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Change in Suprapubic Pain, as measured by the Genitourinary Pain Index (GUPI) questionnaire
The GUPI questionnaire (score range: 0 - 45) contains nine overarching items related to urinary symptoms, pain, and impact on quality of life. Responses to items 1a, 1b, 1c, 1d, 2a, 2b, 2c, 2d, 3 and 4 are used to create a pain subscale with scores ranging from 0 -23, 0 indicating no pain and 23 indicating pain as bad as you can imagine. Responses to items 5 and 6 are used to create a urinary subscale with scores ranging from 0 -10, 0 indicating urinary symptoms are never experienced and 10 indicating they are almost always experienced. Responses to items 7, 8, and 9 are used to create a quality of life impact subscale with scores ranging from 0 -12, 0 indicating no disturbance in quality of life and 10 indicating a large disturbance in quality of life. All subscales are summed to calculate a total score.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Change in Urinary Frequency, as measured by 24-Hour Voiding Diaries
Participants will be instructed on how to complete a 24-hour voiding diary during the initial screening visit. The participant will use a new diary sheet for every 24-hour period with sections identifying time of day (with wake time and bed time indicated by participant), fluid intake (type of fluid ingested and amount in oz), urination (amount in oz voided into urinary hat or urinal), amount of urine drained via catheter if applicable, leaks (any time a participant experienced involuntary urine loss indicated by a check mark in the corresponding time column) if applicable, and pad changes (every time pad was dry indicated by a D in the corresponding time column or with a "S" "M" or "L" if the pad was wet with urine indicating a small, moderate, or large amount in the corresponding time column) if applicable.
Time frame: Baseline, Weeks 1, 2, 3, 4, 8, and 12
Change in Sexual Functioning and Satisfaction, as measured by the Male and Female Patient-Reported Outcomes Measurement Information System (PROMIS) Sexual Function and Satisfaction Brief Profile
The Male and Female PROMIS Sexual Function and Satisfaction brief profile provides participants with questions related to their sexual functioning and satisfaction within the last 30 days. The male version of the questionnaire (score range: 0-50) consists of 10 items, while the female version (score range: 0-70) consists of 14 items. For both of the gender-specific versions, lower scores indicate lower interest, sexual satisfaction, and discomfort while higher scores indicate higher interest, sexual satisfaction, and discomfort.
Time frame: Baseline, Weeks 4, 8, 12, and 16
Change in Perceived Quality of Life, as measured by the McGill Quality of Life questionnaire
The McGill Quality of Life (MQOL) is a self-reported measure that contains 16-items with a single-item global scale used to measure quality of life over a 2-day timeframe. Items are scored 1-10, with 0 indicating the lowest score (not a problem) and 10 indicating the highest score (tremendous problem), for five sub-scales (physical well-being, physical symptoms, psychological, existential, and support). An overall index score can be calculated by summing the means of the five sub-scales to measure overall quality of life.
Time frame: Baseline and Week 16
Plan to share: No
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